1. Field of the Invention
The present invention relates in its broadest aspect to an appliance and a method for cleansing a surface area of the skin such as a wound, a fistula, or an artificial orifice or opening such as the end of an intestine or stoma protruding from the skin of a human body. Thus, the present invention relates to a appliance for cleansing an artificial orifice or opening in the form of the end of an intestine or a stoma and furthermore, an appliance for cleansing surface areas of the skin such as a wound or the area of a drainage site.
In connection with surgery for a number of diseases in the gastro-intestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra is exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also in connection with a fistula, which has developed between an internal organ and the abdominal surface, the patient will have to rely on an appliance to collect the bodily material emerging from such opening. Collecting bags may also be used for collecting exudates from a wound or collection of bodily material in connection with post operation or drainage purposes.
Appliances for such uses are well known and may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer's abdomen, and a collecting member or bag is attached to the ostomy body side member for receiving exudates from the stoma or wound, the collecting member or bag being releasably attached in case of a two-piece appliance.
When using one-piece appliances, the whole appliance, including the adhesive wafer or pad securing the appliance to the skin is removed and replaced by a fresh appliance. When using two-piece appliances, the ostomy body side member is left in place for several days, and only the collecting member or bag is replaced.
The end of the intestine or a protruding stoma will normally be covered by an ostomy appliance for collecting the effluents or waste products of the body, which are conveyed through such artificial orifice or opening and the opening and the surrounding area must regularly be cleansed.
In connection with stomas, wounds, areas of a drainage site or fistulas it is necessary from time to time to change a dressing covering the same and it is also often desirable to rinse the stoma, wound, fistula or drainage area before applying a fresh dressing.
However, in connection with two-piece appliances, the size of the aperture of the flange of the bag is often greater than the size of the apertures of the commonly used body side members, and there is a considerable risk of access of exudates to the distal surface of the adhesive wafer of the body side member. This opens for chemical attack on the adhesive from the “back” and may furthermore give rise to soiling or contamination the distal surface of the body side member, especially in connection with colostomies. This may reduce the wearing time of the body side member and furthermore give rise to problems when substituting the collecting bag with a fresh bag as the coupling area may have to be cleaned in order to ensure a proper coupling and sealing of the fresh bag and also to ensure that residues giving rise to unpleasant odours are not left on the body side member. Altogether there is a considerable risk of having to exchange the body side member before its technical service time has been exhausted.
The same applies to collecting appliances for other purposes such as collecting exudates from a wound or collection of bodily material in connection with post operation or drainage purposes.
2. Description of the Related Art
WO 98/24387 discloses a device for cleansing the end of an intestine protruding from a human body. The cover has an elastic peripheral edge to fit tightly against the surface of the body when placed over a stoma, it is provided with an outlet at the bottom which outlet may be connected to a hose leading to the toilet bowl or other drain, and it is provided with a ball placed in a movable joint and having a through-channel for injection of liquid.
The device disclosed in WO 98/24387 suffers from the drawback that the sealing against the body is depending on the pressure with which it is pressed against the body and that the pressure must be nearly equally distributed along the periphery in order to ensure a safe sealing. Such pressure is difficult to maintain, even for e.g. a nurse cleansing the stoma area when, at the same time, she has to operate the device for allowing liquid to be sprayed over the entire surface covered by the cover. Furthermore, the device is relatively expensive and provided with movable parts and several areas being difficult to cleanse after the use, especially the top edges and the area surrounding the ball as well as the outlet and the surrounding area.
U.S. Pat. No. 4,586,927 discloses an irrigation sleeve for colostomy patients which sleeve can be removeably attached to different snap-on attachments such as an irrigation attachment or rinsing or flushing attachment. The sleeve is provided with a cone shaped body communicating with a conduit from a reservoir, said cone shaped body having the large diameter end pointing away from the patient.
U.S. Pat. No. 5,738,661 discloses a medical device for holding a feeding tube comprising a cone shaped projection for rigid fastening of the tube.
The devices disclosed in U.S. Pat. Nos. 4,586,927 and 5,738,661 do not offer an option to cleanse a surface area of the skin and none of the above-referenced publications offer any solution for avoiding a vacuum in the bag causing the same to collapse giving rise to a risk that visceral contents being cleansed away from a stoma will not immediately be able to separate the walls and “fall” into the bottom of the receiving bag but will rather stay and obstruct the cleaning process as solid pieces of visceral contents are not flushed down.
Thus, there is still a need of cleansing device for cleansing a surface area of the skin such as a wound, a fistula, or an artificial orifice or opening such as the end of an intestine or stoma protruding from the skin of a human body which device is easily operated by one person and provides a safe and reliable sealing against the body, is suitable for cleansing a surface area of the skin of a patient having a wound, a fistula, or an artificial opening such as a stoma, which device reduces the risk that a vacuum may tend to draw the front wall against the rear wall and causing the bag to collapse and which device is preferably a cheap device that may be used as a disposable device in order to avoid laborious cleansing procedures and necessary cleansing facilities.
It has been found that these needs may be fulfilled by the present invention.